Manufacturing Technician III

About Q'apel Medical, Inc About Q’Apel: At Q’Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we’re a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. That’s where Q’Apel comes in. Successful Q’Apel team members step up to the plate and work together to achieve our goals every single day. We are a fast-paced, high-growth company with a startup philosophy that requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude. Position Title: Manufacturing Technician III / Catheter Assembly Technician 3 Job Location: 4245 Technology Drive, Fremont, CA 94538 Worker Category: Full-Time/Non-Exempt Job Industry: Neurovascular Medical Devices (Catheters) Schedule: Monday - Friday Shift: 6:00 AM - 2:30 PM Who We Want: Q’Apel is seeking a Manufacturing Technician 3 / Catheter Assembler to support and maintain efficient, timely, and effective production operations. A minimum of 3-4 years of manual catheter assembly experience in the Neurovascular Devices Industry, Neurointerventional, Endovascular Neurosurgery, Neuro-interventional, Coronary or Peripheral Medical Device sectors is required to be considered. The ideal candidate will have recent hands-on experience assembling neurovascular catheters, demonstrating excellent manual dexterity, visual acuity, strong attention to detail, and the ability to follow strict instructions. The assembly process must be followed exactly from the written Standard Operating Procedures (SOP's) to meet safety and high-quality standards. We're looking for someone who has proven and proficient microscope skills capable of performing detailed assembly and inspection tasks for extended periods (up to 8 hours per day). Can safely and effectively operate manual cutting tools and other assembly equipment. Follows work instructions accurately and consistently to ensure high product quality and deliver on output. The ideal assembly technician must be comfortable working in a dynamic environment with rapidly changing priorities and demonstrate flexibility to quickly adjust to new tasks and assignments as needed. At Q’Apel, every team member “steps up to the plate.” We are a fast-paced, high-growth company with a startup mindset. We value collaboration, adaptability, and a positive attitude toward change. If you thrive in a dynamic environment and take pride in precision work, we’d love to have you on our team. What You’ll Work On: Daily accurate manual assembly associated with the manufacturing technician III of the neurovascular catheter per SOP guidelines. Supports production needs as scheduled and remains flexible. Performsmanufacturinginspectionandtestingof catheter productstoensuretheymeetspecifications. Accurate documentation and consistent records maintenance. Working daily in the controlled environment room (CER). Accurately and consistently follow FDA Quality Systems Regulations and various ISO Solve production issues and identify improvements. Investigateandtestneworrevisedproductionprocedures. Adherestoapprovedstandardoperatingproceduresandmanufacturingprocedures. Unlimited/continuoususeofamicroscope. Unlimited/continuoususeofmanualcutters. Opening,lifting,andpackagingshipperboxesapproximately10lbs.inweightonacontinuous basis. Provide consistent daily product output. Ability to stay flexible and transition from one station to another, one task to another. Daily communication and ability to clearly explain any assembly-related problems. Strong problem-solving skills. Other duties as requested. WhatYouBring: Education: High School degree required Experience&Skills required: Minimum 3-5 years of recent catheter assembly experience required. Good manualdexterityandvisualacuity required. Effectivecommunicationskills(bothwrittenandverbal)required. Abilitytoworkindependentlyorinateamsetting. Abilitytoliftupto10lbs or more Must be organizedandself-motivated Minimum 3-5 years of experience working in a regulated industry (medical device development experience, along with a solid working knowledge of FDA Quality System Regulations and ISO 13485 and other ISOs) Minimum 3-5 years of experience working in a controlled environment room (CER) required Knowledge and exposure to applicable regulations (QSR, MDD, CMDR, and ISO) required Our hourly compensation ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your hourly compensation. The hourly compensation range for this full-time, non-exempt position is between $29.00/hour to $30.00/hour. This document contains confidential, proprietary information of Q’Apel Medical, Inc. It may not be copied or reproduced without prior written permission from Q’Apel Medical, Inc PI00153a117fde-37344-41016045